Celltrion Therapeutic - Product Scorecard

Company: Celltrion

Type: Covid-19 Therapeutic
Product (brand name): Regdanvimab (Regkirona)
0%
compliance
with criteria
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Explore the results of PAF’s research into the behaviour of Celltrion. Each section is given an overall score; individual criteria are also scored (see icon following the criteria heading).

Click on ‘Explanation about the score’ sign next to each entry to expand and learn more.

Category A: Commitments and Accountability

The company should publicly commit to human rights in relation to product development and marketing, by adopting an official human rights policy statement recognising the right to the highest attainable standard of health. The company should endeavour to integrate human rights into its strategies, policies, programmes, projects, and activities.

The company should also have a publicly available global access plan for their Covid-19 product, based on human rights standards, with measurable targets and lines of accountability.

A1: Does Celltrion publish a global access plan for its product?

CellTrion has not published a global access plan for its product.

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A2: Does Celltrion commit to comply with human rights standards in relation to product development and marketing?

Celltrion has a section on ‘social responsibility’ on its website, but does not mention human rights.

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Category C: International cooperation

The company should constructively engage with international initiatives for the equitable distribution of vaccines and therapeutics, such as the Covid-19 Technology Access Pool (C-TAP) or the Medicines Patent Pool (MPP), and the ACT Accelerator (COVAX). The company should also publicly commit to not enforcing the exclusive rights of Covid-19 related patents, and enter into non-exclusive, transparent licensing agreements for its Covid-19 products with other companies.

C1: Does Celltrion commit to C-TAP or MPP?

Celltrion has not committed to C-TAP or the MPP, but was one of 18 generic companies that signed a pledge in November 2020 to work with the Medicines Patent Pool ‘to accelerate access to hundreds of millions of doses of new Covid-19 interventions for low- and middle-income countries’.

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C2: Does Celltrion commit to not enforcing the exclusive rights of Covid-19 related patents?

Celltrion has not committed to not enforcing the exclusive rights of Covid-19 related patents.

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C3: Does Celltrion supply to, or signs agreements with, the vaccines or therapeutics pillar of the ACT Accelerator?

Celltrion has not signed an agreement with the ACT Accelerator.

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C4: Does Celltrion agree to license its Covid-19 medical products to other companies?

Celltrion has not signed a licensing agreement yet, but has signed a pledge with the MPP which includes “working with MPP to negotiate licences for patented effective COVID-19 therapeutics, as they become available.” and “accelerating development and delivery timelines for new treatments with technology transfer support from MPP and originators, as needed.”

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Category E: Equality, non-discrimination & equity

The company should engage in efforts to further equitable distribution of Covid-19 vaccines/therapeutics, by equitably distributing its supplies globally, devising fair pricing strategies, and making the active ingredient for its product available to other manufacturers. The company should also engage in full technology transfer to other manufacturers, including the necessary transfer of skills, legal components, knowledge and intellectual property. Where applicable, the company should agree to waive rights in regulatory test data, and refrain from enforcing TRIPS+ measures.

E1: Does Celltrion make the active ingredient available on reasonable grounds? [Only for therapeutics]

Celltrion has not made the active ingredient for its therapeutic available to other manufacturers so far. However, the MPP pledge states that “Previously, we have worked together by sourcing active pharmaceutical ingredients from each other and expanding distribution networks for finished formulations.” so we can hope that this means Celltrion will also apply this principle to Regdanvimab

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E2: Does Celltrion commit to full technology transfer to other manufacturers?

Celltrion has not committed to full technology transfer yet, but its pledge with the MPP includes “working with MPP to negotiate licences for patented effective COVID-19 therapeutics, as they become available.” and “accelerating development and delivery timelines for new treatments with technology transfer support from MPP and originators, as needed.”

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E3: Does Celltrion commit to non-profit, ‘fair’, or differential pricing?

Celltrion has stated that “We plan to provide our treatment at a more affordable price than other monoclonal antibodies. In addition, the price will be negotiable based on the purchase volume by country.”​ Regkirona is priced at half the cost of Molnupiravir, and will be sold to domestic institutions at cost.

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